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FDA NDA · NDA211226

KHAPZORY

levoleucovorin

Sponsor: ACROTECH BIOPHARMA

APPLICATION
NDA211226
TYPE
NDA
ORIGINAL APPROVAL
2018-10-19
LATEST ACTION
2020-03-03
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Discontinued, Prescription

Products

KHAPZORY · ReferenceDiscontinued
LEVOLEUCOVORIN 300MG/VIAL · POWDER · INTRAVENOUS
KHAPZORY · ReferencePrescription
LEVOLEUCOVORIN 175MG/VIAL · POWDER · INTRAVENOUS

Approval history

2020-03-03Labeling · Supplement 2 · standard — Letter ↗AP
2018-10-19Type 2 - New Active Ingredient · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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